Geodon for the Treatment of Refractory Social Anxiety Disorder

Phase 2

Completed

• Conditions: Social Anxiety Disorder
• Interventions: Drug: Ziprasidone; Drug: Sertraline

• Registration Number: NCT00215150
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to examine the effectiveness and tolerability of augmentation treatment of ziprasidone to achieve remission among patients with social anxiety disorder (SAD) who did not remit on sertraline treatment alone

Detailed Description

This is a two-phase study consisting of 8 weeks of open label treatment with sertraline (50-200 mg/day) in patients with SAD and in those who fail to demonstrate symptom remission on sertraline alone, 8 weeks of randomized, double-blind, placebo-controlled augmentation with ziprasidone.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2008-12
• Study Completion: 2009-07
• Results First Submitted: 2012-12-13
• Status Verified: 2013-04
• Results First Submitted QC: 2013-04-16
• Results First Posted: 2013-05-24
• Last Update Submitted: 2014-10-23
• Last Update Posted: 2014-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• adults 18-65 years of age
• primary diagnosis of SAD, using Diagnostic Standard Manual(DSM-IV) criteria
• minimum Clinical Global Impression of Severity (CGI-S) score of 4 at baseline
• minimum Brief Social Phobia Scale(BSPS) score of 20 at baseline
• written informed consent
• negative serum pregnancy test for women of childbearing potential
• normal EKG

Exclusion Criteria

• current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition
• any current primary anxiety disorder other than SAD
• current primary depression
• history of substance abuse or dependence within the last 3 months
• suicide risk or serious suicide attempt within the last year
• clinically significant medical condition or laboratory or EKG abnormality
• women of childbearing potential who are unwilling to practice an acceptable method of contraception
• patients needing concurrent use of psychotropic medications
• history of hypersensitivity to sertraline or ziprasidone
• recent (less than 2 months) initiation of psychotherapy for SAD
• history of failure to respond to augmentation with an adequate trial of an atypical antipsychotic
• patients who are currently taking any of the following medications: Erythromycin, Biaxin, Avelox, Zithromax, Amantadine, Levaquin, Tamoxifen, Tegretol, Nizoral, and Levitra

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Randomization Ziprasidone	Sertraline	8 weeks of treatment with sertraline augmented with ziprasidone
Open Label Treatment	Sertraline	8 weeks of open label treatment with sertraline
Randomization Ziprasidone	Ziprasidone	8 weeks of treatment with sertraline augmented with ziprasidone
Randomization Placebo	Sertraline	8 weeks of treatment with sertraline augmented by placebo

Primary Outcome Measures

Name	Time	Method
Brief Social Phobia Scale(BSPS)	Baseline, 8 and 16 weeks	An observer measure of social phobic symptoms, referred to as the Brief Social Phobia Scale, consists of 11 items, 7 evaluating commonly feared or avoided situations and 4 additional items measuring autonomic distress. A total numerical range of 0-88 is scored on this measure, with higher scores representing greater severity of social anxiety disorder symptoms.The total score is computed as a simple sum of the 11 items.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States